14 days old

MAP Digital Plant Compliance Lead

Pfizer
Kalamazoo, MI 49007
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**Why Patients Need You** Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.



**ROLE SUMMARY**

The MAP Digital Plant team is tasked with designing, implementing, commissioning, qualifying and supporting the digital systems that will support and enable the manufacturing of aseptic medicines in Pfizer Kalamazoo's world class Modular Aseptic Processing facility. The Digital Plant Compliance Lead will provide strategic and tactical direction on the compliance aspects of all of MAP's digital systems.



Compliance duties include negotiating strategies with quality, leading data integrity assessments, updating and creating strategic standard operating procedures, implementing new methodologies, and mentoring automation engineers in compliance methodology as well as audit representation for automation systems.



**ROLE RESPONSIBILITIES**



+ Improving the compliance footprint for the automation organization by implementing continuous improvement practices for the automation team to follow related to regulatory, corporate, and site policies and practices.

+ Preparation and representation for automation in regulatory and customer audits.

+ Communicating and collaborating with operations and automation colleagues to manage and/or perform user account reviews

+ Updating Data Integrity Assessments and routing them through change control

+ Performing/managing records retention tasks

+ Managing automation department compliance methodologies, strategies, systems and standards including Data Integrity, SOP periodic review, CAS reviews, and other documentation.

+ Assisting Cybersecurity lead with strategy, methodologies and documentation of process and procedures from a compliance perspective.

+ Assisting Infrastructure lead with strategy, methodologies and documentation of process and procedures from a compliance perspective.

+ provide 24x7x365 support of our automation systems from a compliance perspective including assisting automation engineers when emergencies arise to have issue properly addressed and documented.

+ Participate in the Engineering Compliance Services team representing automation.

+ Review system support documentation to ensure compliance

+ clearly communicate progress and issues to peers and management

+ Assist in training and mentoring site Automation Technicians, Analysts, and Engineers.

+ Monitor and trend issues to identify and develop preventative solutions



**BASIC QUALIFICATIONS**



+ Bachelor of Science degree in a technical field such as Electrical, Mechanical, Chemical, or Computer Engineering, or Computer Science.

+ Nine or more years of Automation Engineering experience.

+ Proficiency in Excel, Word, Powerpoint, Sharepoint, Teams

+ Good Organizational skills and can meet project task deadlines

+ Proven ability to work in team environment and contribute as a team member

+ Ability to learn new technologies and adapt to change



**PREFERRED QUALIFICATIONS**



+ The ideal candidate should have background in cGMP regulations and the practical application of those methodologies to control systems.

+ System technical knowledge, such as MS Windows Server, Active Directory, SQL Server, VMware, vSphere, vCenter, Cisco, Networking and OSI PI.

+ Experience building systems and installing patches



**PHYSICAL/MENTAL REQUIREMENTS**

Office and plant environment.

Keyboarding, lifting, standing, bending, walking.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

Weekend and off hours work required, some overtime.

Supporting 24/7 operation - on call coverage.

Adhere to safe work practices

Some travel (including international) required (Approx. 5% of time)



**Other Job Details**



+ **Eligible for Relocation Package**

+ **Eligible for Employee Referral Bonus**



**\#** LI-PFE



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Engineering
Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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MAP Digital Plant Compliance Lead

Pfizer
Kalamazoo, MI 49007

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